The Breast Cancer Survivors and Partners Online Research Together (SUPORT) Project

Phase 2

Recruiting

• Conditions: Breast Cancer Female; Psychological Distress

• Registration Number: NCT05676255
• Lead Sponsor: University of Arizona

Brief Summary

Many breast cancer survivors (estimated 70% in some studies) experience clinically significant depression and/or anxiety in the months and years after finishing cancer treatments. This research will build on the rigor of prior research to reduce breast cancer survivor depression and anxiety with a compassion meditation intervention called CBCT (Cognitively-Based Compassion Training) for online synchronous delivery that is also inclusive of informal caregivers (i.e., adult family members who live with and typically provide half the care for survivors, aka supportive partners).

Detailed Description

The goal of this project is to determine if CBCT (Cognitively-Based Compassion Training) can reduce distress for survivors compared to an attention control (Health Education; HE) when delivered by Zoom to both survivors and caregivers/ supportive partners as a dyad (i.e., CBCT for dyads; CBCT-D). We will also test whether instructing survivors and caregivers/ supportive partners together in CBCT (CBCT-D) reduces distress more than when survivors receive CBCT instruction by themselves, without caregivers/ supportive partners (i.e., CBCT for survivors; CBCT-S). The following specific aims address these questions:

Aim 1: Determine if survivors and caregivers/ supportive partners exhibit less depression and anxiety (primary outcomes) when survivors receive online CBCT along with their informal caregiver// supportive partner (CBCT-D), compared to when survivors receive online CBCT alone (CBCT-S) or when survivors and informal caregivers// supportive partners receive online HE. We will recruit dyads (N=226) consisting of survivors (between 3 months and 5 years post treatments with curative intent, i.e., chemotherapy, radiation, surgery) and their caregivers/ supportive partners. H1: Survivors and caregivers randomized to CBCT-D will exhibit greater improvements in distress (i.e., depression, anxiety; primary outcomes in survivors) at months 2, 3, and 8 versus those randomized to CBCT-S or HE.

Aim 2: Test the extent to which reductions in survivor's depression and anxiety from online CBCT-D are mediated by social connection, dyadic function, and caregiver/ supportive partner distress. H2a: Survivor's social connection and dyadic function will mediate the effects of online CBCT-D versus HE on survivor's distress at months 2, 3 and 8. H2b: Caregiver's social connection, dyadic function, and distress will mediate the effects of CBCT-D versus CBCT-S or HE on survivor's distress.

Aim 3: Explore the effects of online CBCT-D versus CBCT-S and HE on survivor diurnal cortisol rhythm at months 2, 3 and 8, and the extent to which cortisol rhythm is a marker versus mediator of improvements in survivor's distress at month 2, 3, and 8.

Study Timeline

• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2022-12-22
• Study First Posted: 2023-01-09
• Study Start: 2023-03-20
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 452

Inclusion Criteria

• biological sex: woman
• able to speak and understand English
• have a diagnosis of a breast cancer
• have completed primary curative cancer treatments (i.e., surgery, radiation, chemotherapy) except for hormonal therapies (e.g., aromatase inhibitors) or trastuzumab a minimum of 3 months and a maximum of 5 years before starting CBCT or the control
• have a supportive partner (aka caregiver) who can participate with them

Exclusion Criteria

• nursing home resident
• have ongoing (1 or more meditation sessions per week) or past regular meditation experience in the last 4 years (i.e., more than two meditation sessions [completed or attempted] per year, either with a group or individually, to be evaluated by the Principal Investigator)

Supportive partners (aka informal caregivers)

Inclusion Criteria:

• named by the survivor
• live in the same household as the survivor
• able to speak and understand English

Exclusion Criteria:

• have ongoing (1 or more meditation sessions per week) or past regular meditation experience in the last 4 years (i.e., more than two meditation sessions [completed or attempted] per year, either with a group or individually, to be evaluated by the Principal Investigator)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in depression features	Change from baseline depression to 8 weeks after the start of intervention	The difference in the change in depression features between the intervention arms from before to 8 weeks after start of the interventions will be measured with the Patient-Reported Outcomes Measurement Information System short form Depression - 8a.
Change in anxiety features	Change from baseline anxiety to 8 weeks after the start of intervention	The difference in the change in anxiety features between the intervention arms from before to 8 weeks after start of the interventions will be measured with the Patient-Reported Outcomes Measurement Information System short form Anxiety - 8a.

Secondary Outcome Measures

Name	Time	Method
Change in depression features	Change from baseline depression to 32 weeks after the start of intervention	The difference in the change in depression features between the intervention arms from before to 32 weeks after start of the interventions will be measured with the Patient-Reported Outcomes Measurement Information System short form Depression - 8a.
Change in anxiety features	Change from baseline anxiety to 32 weeks after the start of intervention	The difference in the change in anxiety features between the intervention arms from before to 32 weeks after start of the interventions will be measured with the Patient-Reported Outcomes Measurement Information System short form Anxiety - 8a.

Trial Locations

Locations (1)

University of Arizona; 🇺🇸 Tucson, Arizona, United States